Device generator replacement in response to advisories resulted in major complications in 4.1% of patients, emphasizing the need for careful risk assessment.
Observational (n=222)
No
Generator replacement in response to device advisories carries a notable risk of major complications (4.1%), emphasizing the need for careful, individualized risk-benefit assessments before proceeding with replacement.
INTRODUCTION: Device recalls create problems for patients and physicians, for the risks associated with replacement may be greater than the device failure rate. In 2005, Medtronic, Guidant, and St. Jude had implantable cardioverter defibrillator (ICD) recalls on several of their devices. There were no national standards to guide physicians on the management of such patients. We report the reasons for and outcomes of ICD and pacemaker generator changes from our practice resulting from these advisories. METHODS AND RESULTS: After an advisory was issued, the patients with an affected device were contacted, evaluated in the office by one of the electrophysiologists in our group, and a management plan was determined. Two hundred and twenty-two of 1,039 (Medtronic 273, Guidant 766) (21.4%) patients with advisory devices underwent device replacement. Nine minor complications occurred: hematoma managed conservatively (n = 6); local discomfort (n = 1); and incisional infections treated successfully with oral antibiotics (n = 2). Major complications occurred in nine patients (4.1%). Four atrial leads were damaged, two of which were repaired, one during the same procedure and the other at a later date. One patient required a reoperation to tighten a loose ventricular lead set screw. Hematoma requiring evacuation occurred in one patient, and pocket revision was necessary in two patients secondary to severe discomfort due to the positioning of the device in the pocket. One patient had a cerebrovascular accident preoperatively. There were no perioperative deaths or infections requiring system removal. CONCLUSION: Even with experienced operators complications can occur when replacing generators for a device recall. Careful risk assessment for each individual patient should be performed and efforts made to minimize generator changes.
Costea et al. (Thu,) conducted a observational in Patients with implantable cardioverter defibrillator (ICD) or pacemaker devices under advisory/recall (n=222). Device generator replacement was evaluated on Major complications. Device generator replacement in response to advisories resulted in major complications in 4.1% of patients, emphasizing the need for careful risk assessment.